Theme

NSAID gastroprotection · Phase III active-controlled trial

Tegoprazan matched lansoprazole for preventing NSAID-related peptic ulcers over 24 weeks

Source
Source: Gut Liver online-ahead-of-print Phase III randomized, double-blind, active-controlled multicenter trial of tegoprazan for prevention of NSAID-induced peptic ulcer. The study cites ClinicalTrials.gov identifier NCT04840550.

Comparable ulcer prevention and safety, with a week-12 heartburn symptom signal favoring tegoprazan.

24 wk
ulcer prevention endpoint
Design
Phase III, randomized, double-blind, active-controlled, multicenter
Population
392 randomized patients continuing NSAIDs
Arms
Tegoprazan 25 mg vs lansoprazole 15 mg
Duration
Continuous NSAID therapy for up to 24 weeks
Central efficacy finding

Non-inferiority met for prevention of NSAID-induced gastroduodenal ulcers

Primary endpoint
p=0.0004
for non-inferiority at week 24

Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg for the incidence of peptic ulcer after 24 weeks of gastroprotection during continued NSAID treatment.

Investigational arm
Tegoprazan 25 mg
Active comparator
Lansoprazole 15 mg
0 12 24 randomize symptoms ulcers
Key findings

Endpoints and exact reported statistics

Outcome magnitudes not provided in brief; chart omitted
Domain Endpoint / measure Finding Exact statistic
Efficacy Incidence of peptic ulcer at week 24 Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg for prevention of NSAID-induced gastroduodenal ulcers. p=0.0004
non-inferiority
Symptoms Heartburn-free rate at week 12 Favored tegoprazan versus lansoprazole. p=0.0421
between-group difference
GI symptoms Overall gastrointestinal symptom-free rates Similar between tegoprazan and lansoprazole groups. Comparable
Safety Adverse drug reactions and serious adverse events Comparable safety outcomes between groups. Similar tolerability
392
patients randomized 1:1
269
patients in per-protocol analysis
24
weeks of gastroprotective therapy during NSAID use
Treatment comparison
Tegoprazan 25 mg
investigational gastroprotective therapy
Lansoprazole 15 mg
active comparator
Numbers to know
1:1
randomization
12 wk
heartburn-free assessment favored tegoprazan
15 mg
lansoprazole comparator dose
25 mg
tegoprazan dose
AbbreviationsQuick
NSAIDs = nonsteroidal anti-inflammatory drugs; ADRs = adverse drug reactions; SAEs = serious adverse events.
Bibliography1
  1. Kim SG, Kim TO, Jung SW, et al. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jun 22. Online ahead of print. PMID: 42325011. (DOI: 10.5009/gnl260057)